Overview Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges. At Rho, we’re committed to you just as you’re committed to us. You’ll have the opportunity to experience a thriving company with real stability – financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career. With a collaborative team of smart, talented, and positive people, you’ll be celebrated and respected for your expertise and given the freedom to think creatively, challenge the norm, and problem-solve. Why Rho? The foundation of our organization was built on Biometrics, and it continues to be a thriving focal point for our business with strong employee tenure and stability. We are large enough for strong stability, but small enough for you to have strong visibility and exposure to grow your career! Support and collaboration is everywhere – from the top down. You have plenty of artillery to be successful here It’s fun and vibrant – our culture is unbeatable Great benefits, time off and 3 promotion cycles per year! Lastly, we do great work and our studies are properly staffed, that makes for very happy people! As a Senior Statistical Programmer, you’ll have the opportunity to design and write program specifications for CDISC conversions, revise programs for corrections, independently create agency-accepted eSubmission deliverables, review statistical analysis plans and study documents and provide feedback to Biostatistics. You’ll be able to consult with sponsors, internal and external project leads, and other programmers and lead the programming team on multiple studies. Our Statistical Programmers will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group! Responsibilities Lead and participate in the development and validation of high quality CDISC datasets based on the implementation guides and consultations with sponsors, project leads, systems analysts, other programmers, and end users Use your expertise in data standards and regulatory requirements to lead discussions with clients about appropriate approaches to database design Use study protocol, CRF, Data Transfer Agreements from vendors, data sources, CDISC CT, TAUGS, and CDISC implementation guides to independently author SDTM specifications from scratch; use Pinnacle 21 to run data conformance and create define.xml for SDTM and ADaM submissions Act as the CDISC subject matter expert Convert designs and specifications into computer code and analyze code to find causes of errors and revise programs Write and maintain documentation of changes to computer code, programs, and specifications Review user and technical documentation written by others to confirm consistency with program operations Offer expertise relevant to statistical programming and CDASH data collection for study start up, execution, and close out: review protocols, draft CRFs; prepare and review validation plans, review vendor DTAs, etc Modify and maintain software programs written by others Provide mentorship and training to peers and more junior programmers in areas of expertise Ensure effective, accurate and timely communication of key issues and progress to the team and Sr. Management Perform functional lead activities on assigned projects while maintaining scope and budget oversight May provide guidance and input to the budgets and business submissions of proposals Qualifications BA/BS in computer science, statistics, or related field along with at least 5 years performing statistical programming in the SAS language within the CRO/Pharmaceutical industry Extensive experience and understanding in SDTM model including transforming raw data files while adhering to CDISC standards from end to end (raw data to eSub); advanced understanding of SDTM model and experience with ; both specification, programming, and conformance of SDTM CDISC; strong CDISC skills with an emphasis on SDTM End to End submissions experience ADaM model and experience with both specification, programming, and conformance of ADaM CDISC is a plus SAS/Base knowledge with an emphasis on data step programming; competency modifying pre-existing SAS code, as well as writing SAS code from specs. Clinical trials including knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Data/submission conformance tools (such as P21), creation of define.xml, SDSP, and study data reviewer’s guides Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho’s. Committed to Quality: Every job at Rho requires an attention to detail, a deep understanding of our high-quality scientific standards, and an ability to care about every outcome. High-Character: Contribute to our collaborative culture with honesty and integrity. At Rho, we value a strong team spirit highlighted by loyalty, accountability, and mutual trust. We work smart together, we work hard together, and we laugh together. We take responsibility for our actions, forgive honest mistakes and respect one another. Critical Thinker: Rho values thinking. Draw on your native ingenuity, sharpened and enhanced by our intellect, training, and experience. We evaluate situations and opportunities objectively and incisively; we then craft novel, practical solutions. Agile and Adaptable: Rho values the ability to change quickly. We eagerly anticipate, respond to, and take advantage of changes in our environment. We embrace risk but manage it by planning, accepting, and learning from both failures and successes. The opportunity to adapt and evolve energizes us. A few more things to know about us: Benefits: Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k). All employees are eligible for paid time off, holidays, parental leave and bereavement leave. Diversity and Inclusion: As a global, full-service CRO driven by our collective experiences, we view each of our backgrounds as a vital component in our formula for success and we strive towards building a more equitable, inclusive, and diverse environment for our employees every day. By valuing and tapping into each employee’s unique and different personal experiences, we are able to uplift employee dignity and belonging, foster more strategic creativity, and more quickly arrive at breakthrough solutions that help us heal the world. Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work. As required by pay transparency laws in some states, Rho provides the range of starting compensation (annual salary or hourly rate) it reasonably expects to pay for a given role. Actual compensation is influenced by a wide array of factors including but not limited to role responsibilities and location as well as candidate skill set and level of experience. The range of starting pay for this role is $110,000-$150,000 per year EOE. Veterans/Disabled #Biometrics
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